Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain

February 10, 2025 updated by: Saadyya Ahmed Abdalhamed Aladawi
The purpose of this study is to determine whether scapular stabilization exercises can help breastfeeding women with non-specific neck pain by reducing their neck pain, cervical range of motion, and neck disability index.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The best infant feeding practice is breastfeeding, which has both immediate and long-term advantages for mothers, babies, the environment, the economy, and society as a whole. Mothers who are nursing frequently experience neck pain. Because the scapula and neck are closely related, scapular stabilization is becoming more and more popular for patients with neck pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Saadyya A. Abdalhamed Aladawi, Asst Lect
  • Phone Number: 00201116364807
  • Email: dr.saadyya@gmail.com

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt, 12613
        • Recruiting
        • Faculty of Physical Therapy/ Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. exclusive breastfeeding mothers with immediate to 6-month-old infants.
  2. The bilateral cradle position is employed by patients when nursing.
  3. Patients had mechanical neck pain.
  4. Patients with a body mass index below 30 kg/m²
  5. Patients have moderate pain intensity, ranging from 3 to 7 on the visual analogue scale
  6. The patients' scores on the Neck Disability Index ranged from 10 to 40 out of 50.

Exclusion criteria:

  1. Patients had preterm babies or low-birth-weight babies.
  2. pregnant patients
  3. Patients had postpartum complications.
  4. Patients had inflammation, infection, severe degeneration, congenital deformity, and trauma.
  5. Patients had sensory abnormalities or a positive motor reflex.
  6. Patients had cancer, metabolic, or systemic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
Got a standard physical therapy program, muscle energy technique for (sternocleidomastoid, elevator scapulae, upper trapezius and pectoralis major) and advice
Other: Muscle Energy Technique
Muscle Energy Technique for the 1.sternocleidomastoid 2. levator scapulae 3. upper trapezius 4. pectoralis major Through mild isometric contractions, it uses the intrinsic energy of a muscle to lengthen it and induce relaxation through autogenic inhibition.
Other Names:
  • Post Isometric Relaxation
  • Autogenic Inhibition
Other: Advice about the right the breastfeeding ergonomic.
The patients sit with their backs supported with pillows. Don't lean over the infant. Keep the arms supported and feet on the ground.
Experimental: Experimental group
got the same conventional physical therapy program plus scapular stabilization exercises.
Other: Muscle Energy Technique
Muscle Energy Technique for the 1.sternocleidomastoid 2. levator scapulae 3. upper trapezius 4. pectoralis major Through mild isometric contractions, it uses the intrinsic energy of a muscle to lengthen it and induce relaxation through autogenic inhibition.
Other Names:
  • Post Isometric Relaxation
  • Autogenic Inhibition
Other: Advice about the right the breastfeeding ergonomic.
The patients sit with their backs supported with pillows. Don't lean over the infant. Keep the arms supported and feet on the ground.
Other: scapular stabilization exercises
Cools exercise using the Thera-Band, including sidelying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation, and prone extension exercises to promote lower trapezius and middle trapezius activity with minimal activation of the upper trapezius part.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
functional neck disability
Time Frame: at beginning of the study and after four weeks of treatment
The Arabic version of the Neck Disability Index Questionnaire (NDI) is used to assess the functional neck disability. It consists of 10 items; each item scores from 0 to 5, where a score of 0 indicates no limitation and a score of 5 indicates maximum limitation.
at beginning of the study and after four weeks of treatment
neck pain intensity
Time Frame: at beginning of the study and after four weeks of treatment
The Visual Analog Scale VAS was used to assess neck pain intensity for both groups at the beginning of the study and after four weeks of treatment. It is a 10 cm line. 0 means no paint and 10 means maximum pain and the patient chooses a point on the line which reflects the pain
at beginning of the study and after four weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pressure pain threshold
Time Frame: at beginning of the study and after four weeks of treatment
The local pressure pain threshold over the upper trapezius was measured using a pressure algometer. It is a portable digital algometer that responds linearly to force applications between 0 and 1300 kPa, or roughly 0 and 14 kg. With a 1-cm² circular rubber tip, the device measures the maximum force applied before the subject verbally indicates that the pain threshold has been reached.
at beginning of the study and after four weeks of treatment
cervical range of motion
Time Frame: at beginning of the study and after four weeks of treatment
The cervical range of motion (flexion, extension, lateral flexion (Rt & Lt), and rotation (Rt & Lt)) is measured with a universal goniometer.
at beginning of the study and after four weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saadyya Ahmed Abdalhamed Aladawi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Dr. Amel M. Yousef, Prof., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • scapular stabilization ex.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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